Prevention and Treatment of Diabetes in Adults
Addressing Disparity in Diabetes Prevention Through Digital Health Supported PRe-diabetes Intervention, Management and Evaluation (PRIME) Program Based in Malaysian Community Pharmacies
1 other identifier
interventional
91
1 country
1
Brief Summary
Currently, an estimated 3.9 million Malaysians continue to live with diabetes with many more who live with prediabetes. Diabetes was the one of the leading causes of death in the Malaysia and the leading cause for kidney failure, lower-limb amputations, and adult-onset blindness. Heart disease and stroke are two to four times more likely for individuals with diabetes. The use of mHealth or mobile health application can reduce blood sugar among individuals with prediabetes but also prevent a later occurrence of diabetes. In this study, the investigators aim to develop and evaluate the effectiveness of a digital health supported pre-diabetes management program based in an urban community pharmacy setting
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2021
CompletedFirst Posted
Study publicly available on registry
April 6, 2021
CompletedStudy Start
First participant enrolled
March 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedNovember 22, 2024
March 1, 2024
2.2 years
April 3, 2021
November 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body weight
Weight Loss by % of change and total weight change (kg)
Baseline, 1 month, 3 months, 6 months, 12 months
Secondary Outcomes (7)
Incidence of diabetes
12 months
Change in hemoglobin A1c
Baseline, 3 months, 6 months, 12 months
Change in health related quality of life
Baseline, 1 month, 3 months, 6 months, 12 months
Change in dietary practice
Baseline, 1 month, 3 months, 6 months, 12 months
Change in physical activity
Baseline, 1 month, 3 months, 6 months, 12 months
- +2 more secondary outcomes
Study Arms (2)
Intervention arm
EXPERIMENTALParticipants receiving the phone app together with a fitness tracker. All participants will receive the educational curriculum through the app over a period of 24 weeks. The mobile app allows secure patient monitoring through a participant dashboard that the coach can use to increase patient adherence and motivation to achieve goals. The participants can use the app to log their food intake, weight, steps, exercise, in addition to participating in the peer support via the chat function. Participants will also receive regular care and follow up in community pharmacies for support.
Usual care arm
ACTIVE COMPARATORThe control group will be a "usual care" condition in which participants are free to seek any assistance for their medical care during the study period. Participants will be given physical tracking sheets to record their food intake, weight, steps and exercises.
Interventions
Participants will be issued a fitness tracker, Bluetooth enabled glucometer, and a custom developed app which they can communicate digitally to the study investigators either as a group or individually. In the beginning of the study, participants will be taught on how to use the program, how to interact with their coach, and the importance of maintaining motivation throughout the program. Participants will have access to a pharmacist-participant messaging, group messaging, daily challenges for behavior change, education articles (biweekly bite-sized content over 24 weeks), food logging, steps and exercise logging, and feedback. They will be asked to log their weight, meals, and physical activity within the program on a weekly basis. Pharmacist will monitor participant progress through a web-based dashboard. Community pharmacist will be assisting users in setting specific, measurable, attainable, realistic, and time-based goals on a weekly basis.
Participants will be issued a fitness tracker and Bluetooth enabled glucometer but these functions will not be enabled or linked to any app. All participants will be given physical tracking sheets to log in their food intake, blood glucose levels and food diary but will not have access to a personal coaching. Participants are free to seek any assistance for their medical care during the study period.
Eligibility Criteria
You may qualify if:
- Aged 18 years and above
- BMI 23 and above
- HbA1c 5.7 - 6.4% or FPG 5.6mmol/L - 6.9mmol/L
You may not qualify if:
- Unable to give informed consent
- Pregnant or lactating
- Established diabetes
- Terminal illness
- Does not own a mobile phone
- Plans to relocate to an area or travel plans that do not permit full participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Monash Universitylead
- Caring Pharmacycollaborator
- Bionime Corporationcollaborator
- Tigas Pharmacollaborator
Study Sites (1)
Shaun Lee
Subang Jaya, Selangor, 47500, Malaysia
Related Publications (1)
Teoh KW, Ng CM, Chong CW, Cheong WL, Ng YL, Bell JS, Lee SWH. A digital health-supported and community pharmacy-based lifestyle intervention program for adults with pre-diabetes: a study protocol for a cluster randomised controlled trial. BMJ Open. 2024 Oct 23;14(10):e083921. doi: 10.1136/bmjopen-2024-083921.
PMID: 39448216DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shaun Lee
Monash University Malaysia
- PRINCIPAL INVESTIGATOR
Chun Wie Chong
Monash University Malaysia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Cluster randomisation with blinding of statisticians
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 3, 2021
First Posted
April 6, 2021
Study Start
March 23, 2022
Primary Completion
June 15, 2024
Study Completion
June 30, 2024
Last Updated
November 22, 2024
Record last verified: 2024-03